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510(k) Data Aggregation
(90 days)
DORO QR3 XTom Headholder System
The DORO® QR3 XTom Headholder System is a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging with a CT-Scanner is used.
The DORO® QR3 XTom Headholder System ensures an adequate positioning of a patient's head for neurosurgery. Due to the utilized material the device can be used for intraoperative CT imaging procedures. The DORO® QR3 XTom Headholder System consists of the following: Skull Clamp, Skull Pins, Base Unit, Torque Screw Driver and U-Belt. The Base Unit is used to connect the Skull Clamp (including Skull Pins) to the OR-Table. Additional components like the Torque Screw Driver and U-Belt supports the performance of the Headholder System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DORO® QR3 XTom Headholder System.
It's important to note that the provided text is an FDA 510(k) summary for a mechanical support system (Neurosurgical Head Holder/Skull Clamp) and not an AI/ML medical device. Therefore, the questions related to AI/ML specific aspects like training data, expert consensus for ground truth, MRMC studies, and various performance metrics like sensitivity, specificity, AUC are not applicable to this type of device. The acceptance criteria and performance are based on mechanical and usability testing.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied by "Pass" Result) | Reported Device Performance |
|---|---|---|
| DORO® QR3 XTom Headholder System (System Test) | Ability of the system to sustain a certain load without mechanical failure. | Pass: The System supports the static load without mechanical failure. |
| DORO® QR3 XTom Headholder System (Usability) | Usability of the System is given. | Pass: The usability of the System is given. |
| DORO® QR3 XTom Skull Clamp (Static Load - Latching teeth mechanism) | The interface must withstand the static load over the defined duration without damage or malfunction. | Pass: The interface must withstand the static load over the defined duration without damage or malfunction. |
| DORO® QR3 XTom Skull Clamp (Torque - Rocker Arm) | The Rocker Arm must withstand the torque without damaging, opening, or malfunction of the Open-Lock mechanism. | Pass: The Rocker Arm must withstand the torque without damaging, opening or malfunction of the Open-Lock mechanism. |
| DORO® QR3 XTom Skull Clamp (Creep Test) | The skull clamp must maintain the applied maximum force for a defined time without a force deviation from the initially applied load by a defined value. | Pass: The skull clamp must maintain the applied maximum force for a defined time without a force deviation from the initially applied load by a defined value. |
| DORO® QR3 XTom Skull Clamp (Force Delivery Accuracy Verification) | The skull clamp force delivery component must be verified at each major graduation throughout its range for a defined time to deliver the stated force within a defined range of the actual setting. | Pass: The skull clamp force delivery component must be verified at each major graduation throughout its range for a defined time to deliver the stated force within a defined range of the actual setting. |
| DORO® XTom U-Belt (Dynamic Load) | The Belt must withstand the dynamic load without breakage or opening of the Belt. | Pass: The Belt must withstand the dynamic load without breakage or opening of the Belt. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of units tested. It states "The devices have been tested as a system and single device," implying that at least one of each (system, skull clamp, U-Belt) was subjected to testing. For mechanical tests, the sample size might be small, typically 1 to 3 units, as per engineering testing standards, unless statistical significance for variability is a concern.
- Data Provenance: The manufacturer is "pro med instruments GmbH" located in "Freiburg im Breisgau, Germany." This suggests the testing and data likely originated from Germany. The document indicates these were direct performance tests on the physical device, not retrospective or prospective patient data studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable (N/A). As this is a mechanical device, ground truth for its performance is established through objective physical measurements and engineering standards, not through expert human interpretation or consensus like in AI/ML image analysis.
4. Adjudication Method for the Test Set
- N/A. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation (like radiology reads) to resolve disagreements or establish consensus. For mechanical performance tests, the results are quantitative and objective, not subject to human interpretation disagreement in the same way.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This type of study is relevant for diagnostic imaging AI/ML devices to assess the impact on human reader performance. This device is a mechanical support system, not an imaging interpretation aid.
- Effect Size: N/A, as no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- N/A. This is a mechanical device, not an algorithm or software. Its performance is inherent to its physical design, materials, and manufacturing, not dictated by an algorithm.
7. The Type of Ground Truth Used
- Objective Mechanical Measurements and Engineering Standards: The "ground truth" for this device's performance is derived from its ability to meet predefined physical requirements (e.g., load bearing, torque resistance, force accuracy, maintaining clamping force over time) as measured by calibrated testing equipment and adherence to established engineering principles and safety margins. The "Pass" results confirm it met these criteria.
8. The Sample Size for the Training Set
- N/A. This device does not involve machine learning; therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- N/A. Since there is no training set, this question is not applicable.
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